Cleared Traditional

K163668 - SUITESTENSA

K163668 is an FDA 510(k) clearance for SUITESTENSA, manufactured by Ebit Srl. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K163668 · Ebit Srl · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
178d
Days
Class 2
Risk

K163668 is an FDA 510(k) clearance for the SUITESTENSA. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Ebit Srl (Genova, IT). The FDA issued a Cleared decision on June 23, 2017 after a review of 178 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

FDA 510(k) Submission Details - K163668

510(k) Number K163668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2016
Decision Date June 23, 2017
Days to Decision 178 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 107d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

Navigant Consulting, Inc.
Allison Scott

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 2270
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K163668.
Arterys Viewer
K171544 · Arterys, Inc. · Jul 2017
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Enterprise Imaging XERO Viewer 8.1
K170434 · Agfa Healthcare N.V. · Jul 2017
EchoPAC Software Only, EchoPAC Plug-in
K170847 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jun 2017
syngo Application Software
K170747 · Siemens Medical Solutions USA, Inc. · Jun 2017
Vitrea Software Toshiba Package
K171222 · Toshibamedical Systems Corporation · Jun 2017
K163668 · SUITESTENSA
Download PDF FDA Summary Ebit Srl